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| ID | Type | Description | Link |
|---|---|---|---|
| NHPD 115797 |
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| Name | Class |
|---|---|
| Alberta Children's Hospital | OTHER |
| Alberta Health services | OTHER |
| Alberta Heritage Foundation for Medical Research | OTHER |
| SickKids Foundation |
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The purpose of this study is
An orthomolecular treatment approach that combines supplements has, to date, not been tested, although it is commonly used by naturopathic practitioners to treat respiratory problems in individual children. A well-designed controlled trial is needed to determine if this approach is effective. This smaller study should establish guidelines for a large trial to follow. This proposed research is particularly important, as the trend to use natural treatments may encourage non-compliance with conventional medical treatments, leading to poor asthma control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthomolecular Therapy or Placebo Comparator | Dietary Supplement | The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercetin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product. Eligible patients will be randomized to an orthomolecular treatment regime or placebo with a 2:1 randomization ratio and will remain on their randomized treatment for 16 weeks. For the first 8 weeks of the intervention period inhaled corticosteroid treatment will be unchanged. In the remaining 8 weeks dose adjustment will occur every two weeks. Participants will be monitored closely for changes in their lung function. |
| Measure | Description | Time Frame |
|---|---|---|
| The last tolerated dose of inhaled corticosteroids will be the primary end point. | To safeguard against the possibility of excessive adverse events related to the tapering procedures or the orthomolecular treatment, an interim analysis will be conducted after 50% accrual is reached in this pilot investigation. |
| Measure | Description | Time Frame |
|---|---|---|
| The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint. | See primary endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Moritz, MSc | Contact | (403) 220-0022 | 103 | s.moritz@cinim.org |
| Asthma Trial Coordinator | Contact | (403) 220-0022 | 106 | asthma@cinim.org |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Moritz, MSc | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Badri Rickhi, MB,BS,FRCPC | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| Label | URL |
|---|---|
| Canadian Institute of Natural and Integrative Medicine, Calgary | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D009974 | Orthomolecular Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
| Lotte & John Hecht Memorial Foundation | OTHER |
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|
|
| Hude Quan, MD, PhD | University of Calgary | Principal Investigator |
| Sheldon Spier, MD,CM,FRCPC | Alberta Children's Hospital | Principal Investigator |
| Mary Noseworthy, MD, FRCPC | Alberta Children's Hospital | Principal Investigator |
| Eric Arrata, ND | Paradigm Health Group | Principal Investigator |
| Trevor Hoffman, ND | Paradigm Health Group | Principal Investigator |
| Paul Saunders, PhD, ND | Canadian College of Naturopathic Medicine | Principal Investigator |
| Sunita Vohra, MD,FRCPC,MSc | University of Alberta | Principal Investigator |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |